Director, Clinical Program Quality and Excellence

About the role:
Director, Clinical Program Quality & Excellence (CPQE) leads risk-based quality management across assigned clinical programs to ensure inspection readiness, regulatory compliance, and proactive quality oversight throughout the clinical trial lifecycle. Partners with global cross-functional stakeholders to identify emerging risks, resolve issues, and strengthen quality performance to support patient safety, data integrity, and successful regulatory submissions.

How you will contribute:
- Lead quality management for assigned clinical development programs using proactive, risk-based oversight
- Advise asset-level governance bodies (Global Program Teams, Clinical Sub-Teams, Clinical Review Boards)
- Identify, escalate, and mitigate quality risks and critical issues
- Lead investigations of significant quality events (e.g., GCP Serious Breaches, scientific misconduct, major compliance deviations)
- Develop and execute inspection readiness strategies
- Lead global GCP inspection planning/preparation; serve as SME during regulatory interactions
- Design and implement risk-based audit strategies
- Partner with Study Execution Teams to strengthen quality oversight models and real-time inspection readiness
- Mentor Clinical Program Quality professionals; foster accountability, quality by design, and continuous improvement
- Drive cross-functional issue resolution and best-practice adoption
- Contribute to R&D Quality continuous improvement (lessons learned, inspection insights, quality trends)
- Influence senior stakeholders to protect patient safety and data integrity

What you bring to Takeda:
Required:
- BS in scientific/medical/healthcare or related discipline
- 10+ years in pharma/biotech/healthcare
- 5+ years in Quality/Compliance/Clinical Development Quality (or related)
- Deep GCP knowledge; experience from study start-up through regulatory submission
- Experience leading quality oversight, inspection readiness, audit programs, compliance initiatives
- Root cause analysis for quality/compliance issues
- Ability to influence senior leaders; strong communication/leadership/organizational skills

Preferred:
- Advanced degree (MS, PharmD, PhD, MD, or equivalent)
- Experience with regulatory inspections/health authority interactions
- Clinical portfolio governance & risk management
- Background in clinical operations, pharmacovigilance, or quality systems
- Experience leading complex remediation and continuous improvement
- Quality-by-design and risk-based quality management expertise